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CASE STUDY

Hold Up Volume Study

Background

Hold-up volume is crucial in determining the minimum filling volume of the product, impacting the safety and efficacy of clinical administration. The hold-up volumes of vials and syringes were evaluated through experiments simulating clinical drug preparation operations.


Result

The weights of containers and syringes were collected for each operation to analyze the variance between different operators, creating a control chart using SPC (Statistical Process Control) statistical method. Process capability analysis of hold-up and deliverable volumes indicated that the minimum overfill volume could be reduced, leading to significant cost savings.


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Figure 1. One Way Analysis for Different Analysts


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Figure 2. Control Chart of Hold Up Volume



CASE STUDY